Efficacy of Rectal Infiltration of Exparel for Analgesic Benefit Following Hemorrhoidectomy

NCT02104414 | Terminated Phase 4 Results DMC

• 1 other identifier: 13-0062
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the quality and duration of pain relief after a hemorrhoidectomy, provided by locally administered liposomal bupivacaine versus bupivacaine hcl or control with saline. It is hypothesized that liposomal bupivacaine will provide more effective postoperative pain relief than both bupivacaine hcl and the control.

Conditions

Hemorrhoid

Keywords

Liposomal Bupivacaine; Exparel

Outcome Measures

Primary Outcomes (1)

• Post Operative Pain Control

  The primary objective is to evaluate analgesia following local infiltration of 30 mL Exparel or the same volume of 0.25% bupivacaine HCl with epinephrine or normal saline. The intensity of pain will be measured using a numerical rating scale (NRS-11) in which 0 represents no pain, and 10 represents extreme pain.

  up to 4 days

Secondary Outcomes (5)

• Number of Oxycodone Tablets Taken

  up to 4 days

• Postoperative Opioid Consumption - Hydromorphone I.V

  1 hour and 2 hours post op

• Number of Participants With Postoperative Nausea and Vomiting

  up to 4 days

• Number of Participants With Pain During Bowel Movements

  Hourly from PACU arrival to discharge and Q4H from 10:00-22:00 postoperatively for 4 days

• Number of Participants With Urinary Retention

  up to 4 days

Study Arms (3)

Exparel

ACTIVE COMPARATOR

266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)

Drug: Exparel

Bupivacaine HCl with epinephrine

ACTIVE COMPARATOR

75mg/30mL 0.25% Bupivacaine HCl with epinephrine

Drug: Bupivacaine HCl with Epinephrine

Normal Saline

PLACEBO COMPARATOR

30mL Normal Saline

Drug: Normal Saline

Interventions

Exparel DRUG

266 mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)

Also known as: Liposomal Bupivacaine

Exparel

Bupivacaine HCl with Epinephrine DRUG

75mg/30mL 0.25% Bupivacaine HCl with epinephrine

Bupivacaine HCl with epinephrine

Normal Saline DRUG

30mL Normal Saline

Normal Saline

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing hemorrhoidectomy for grade 3 or 4 hemorrhoids who are English-speaking patients, 21-65 yr of age, ASA physical status I-III, BMI\<30

You may not qualify if:

• contraindications to administration of local anesthesia (e.g., local anesthetic allergy), difficult airway (Mallampati\>2), psychiatric or cognitive disorders, pregnancy , and history of substance abuse or chronic opioid use

Sponsors & Collaborators

• St. Luke's-Roosevelt Hospital Center: lead

Study Sites (1)

St.Luke's-Roosevelt Hospital Center

New York, New York, 10027, United States

Location

MeSH Terms

Conditions

Hemorrhoids

Interventions

Bupivacaine; Epinephrine; Saline Solution

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Ali Shariat
• Organization: Mount Sinai St. Luke's

alishariatmd@gmail.com

914-409-5023

Study Officials

• Ali Shariat, MD

  St. Luke's-Roosevelt Hospital Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 4, 2014
• Study Start: April 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: December 4, 2018
• Results First Posted: December 4, 2018

Record last verified: 2018-12

Locations

US (1)